Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Shockwave Medical, Inc.
380 participants
Jan 4, 2022
INTERVENTIONAL
Conditions
Summary
To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.
Eligibility
Plain Language Summary
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Interventions
Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
No device is implanted
Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Locations(95)
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NCT05102019